The present invention relates to phytoestrogen supplements and, more particularly, to phytoestrogen supplements derived from botanical sources which can be administered in a variety of ways.
Steroidal estrogens are typically derived from animal sources and are used to treat conditions such as menopause. Menopause occurs as ovarian function gradually declines, leading to the cessation of ovulation, menstruation and finally secretion of estrogen by the ovaries. The decline and cessation of estrogen secretion leads to a number of symptoms, including hot flashes, mood disturbances such as depression, atheromatous disease and osteoporosis.
Although animal-derived steroidal estrogens, such as estradiol, estratiol and estrone, can be successfully used to treat these symptoms, many women are reluctant to take these substances, and many medical professionals are equally reluctant to prescribe them. These estrogens have been linked to an increase in cancer in women to whom they were administered. Thus, it would be advantageous to find a substance or group of substances which mimic the desirable effects of estrogens, namely the cessation of symptoms associated with menopause, yet which are not carcinogenic.
Phytoestrogens are non-steroidal compounds found in a variety of plants, which exert estrogenic effects in animals. Phytoestrogens from botanical materials may reduce the frequency of hot flashes in Japanese women. Such phytoestrogens were shown to be excreted at a high level in the urine of these women, and are associated with a high level of intake of soy products which contain phytoestrogens [Adlercreutz, H., Hamalainen, E., Gorbach, S. and B. Goldin, The Lancet, 1992, 339:1233]. Estrogenic effects were shown in postmenopausal women after dietary supplementation with soy flour and linseed, which contain phytoestrogens [Wilcox, G. Wahlqvist, M. L., Burger, H. G. and G. Medley, British Medical Journal, 1990, 301:905-6].
Such phytoestrogens are known to be present in pomegranate seeds. The level of phytoestrogens was measured by preparing an acetone extract of the pomegranate seeds and then subjecting this extract to HPLC (High Performance Liquid Chromatography) [Moneam, N. M. A., El Sharaky A. S. and M. M. Radreldin, Journal of Chromatography, 1988, 438:438-442]. Both non-steroidal phytoestrogens and steroidal estrogen were found in the extract.
The estrogenic activity of another preparation of pomegranate seeds has also been described in ovariectomized mice and immature rabbits [A. Sharaf and S. A. R. Nigm, Journal of Endocrinology, 1964, 29:91-92]. This preparation was made by extracting the pomegranate seeds with ether and showed clear estrogenic activity in both the mice and the rabbits, specifically measured by cornification of the vaginal cells and an increase in uterine weight.
The presence of sex hormone-like substances in milk from immature coconuts has also been demonstrated [B. Punghmatharith, Warasan Songkhla Nakkharin, 1988, 10:221-226]. Furthermore, these substances were shown to have estrogenic activity in rats, altering the uterine growth in these animals.
As noted above, a number of botanical materials have been shown to contain phytoestrogens, such as soybeans from Soja max. Other sources of phytoestrogens include Glycyrrhiza glabrata or liquorice, Medicago sativa or alfalfa and Malus sylvestris or apple [K. R. Price and G. R. Fenwick, Food Additives and Contaminants, 1985, 2:73-106].
Although such phytoestrogens have only recently come to the attention of Western medicine, the use of plants to treat female patients for conditions related to the reproductive system has been shown in Chinese medicine for hundreds of years. For example, Chinese angelica root (Angelica sinensis), Chinese licorice root (Glycyrrhizae uralensis), Chinese asparagus root (Asparagus lucidus) and schizandra berries (Schizandra chinesis) have all been used in Chinese herbal medicine to treat female patients, specifically for complaints concerning the reproductive system [Chinese Tonic Herbs, by R. Teeguarden, Japan Publications, New York, 1985]. Typically, preparations containing these botanical materials were given orally, and were considered to be highly effective.
Other examples of botanical preparations include skin creams. A cream for oily skin has been prepared which includes a carbonic acid extraction of rinds and seeds of pomegranates, as described in USSR Patent No. 1,602,533. However, such an extract has the disadvantage of being prepared with carbonic acid, rater than with a less toxic solvent. Furthermore, no suggestion was made that such an extract could also be used as an oral phytoestrogen supplement, rather than simply as a topically applied skin cream. Certainly, if such an extract were to be used orally, a less toxic solvent would be needed.
There is thus a widely recognized need for, and it would be highly advantageous to have, an oral phytoestrogen supplement prepared from pomegranate material, such as pomegranate seeds, as well as a skin cream prepared from such material. Furthermore, it would be advantageous to include other botanical sources of phytoestrogens for increased effectiveness of the oral supplement and skin cream. Finally, it would be advantageous to use these sources of phytoestrogens in a vaginal cream.